UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009567 |
|---|---|
| Receipt number | R000011226 |
| Scientific Title | Evaluation of efficacy of Sitafloxacin in treatment of moderate to severe acute rhinosinusitis |
| Date of disclosure of the study information | 2012/12/18 |
| Last modified on | 2014/06/17 10:52:49 |
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Basic information
Public title
Evaluation of efficacy of Sitafloxacin in treatment of moderate to severe acute rhinosinusitis
Acronym
Evaluation of efficacy of Sitafloxacin in treatment of moderate to severe acute rhinosinusitis
Scientific Title
Evaluation of efficacy of Sitafloxacin in treatment of moderate to severe acute rhinosinusitis
Scientific Title:Acronym
Evaluation of efficacy of Sitafloxacin in treatment of moderate to severe acute rhinosinusitis
Region
| Japan |
Condition
Condition
acute rhinosinusitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective of this study is to evaluate the clinical efficacy of Sitafloxacin (200mg/day) in treatment of patients with moderate to severe acute rhinosinusitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical efficacy judged by the scoring system at the end of the medication or at the end of observation period
Key secondary outcomes
Bacteriological efficacy at the end of the medication or at the end of observation period
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sitafloxacin Tablets 50 mg (200mg/day)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) 16 years or older
(2) Male or Female
(3)Diagnosed as moderate or severe in the clinical severity
(4) Patients who fulfill all following criteria at the start of the medication or 1day before and determined to be bacterial infectious disease.
(a)Purulent or mucopurulent rhinorrhea or postnasal drip
(b)Facial pressure or facial pain / frontal headache
Key exclusion criteria
(1)Patients with history of hypersensitivity to quinolone
(2) Patients with history of convulsive disorder (e.g. Epilepsy)
(3)Pregnant or lactating women
(4)Severe heart diseases or hepatic dysfunction
(5) Moderate or severe renal dysfunction
(6) Severe underlying disease; patients in which clinical evaluation is difficult because of confounding diseases
(7) Patients showing improvement of symptoms by the other antibiotic therapy
(8) Administration of Sitafloxacin 7 days before starting Sitafloxacin
(9)For other reasons, patients determined to be inappropriate for study entry by investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yorihiko Ikeda |
Organization
Wakayama Medical University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
811-1 Kimiidera, Wakayama-shi, Wakayama 641-8509, Japan
TEL
073-447-2300
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Fukuta |
Organization
Wakayama-Okayama Otolaryngology Pharma
Division name
secretariat
Zip code
Address
23-16-2 Kaminakano, Kita-ku, Okayama-shi, Okayama 700-0972, Japan
TEL
Homepage URL
woop@calo.co.jp
Sponsor or person
Institute
Wakayama-Okayama Otolaryngology Pharma
Institute
Department
Personal name
Funding Source
Organization
Wakayama-Okayama Otolaryngology Pharma
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 17 | Day |
Last modified on
| 2014 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011226
